SonoVue®-Enhanced Ultrasound (US) Versus Unenhanced US for Focal Liver Lesion Characterization

Bracco

Status and phase: Completed; Phase 3

Conditions: Liver Neoplasms

Treatments: Drug: SonoVue®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00829413

BR1-130

Details and patient eligibility

About

The purpose of this study is to demonstrate the Sensitivity and Specificity of SonoVue®-enhanced ultrasound is superior to that of unenhanced ultrasound for the characterization of benign versus malignant FLLs using final diagnosis based on histology or combined imaging (CE-CT and/or CE MRI)/clinical data as truth standard.

Full description

Unit of analysis for the outcome measures was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.

Enrollment: 353 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male/female.
• Provides written Informed Consent and is willing to comply with protocol requirements.
• Is at least 18 years of age.
• Has at least 1 FLL (target lesion) requiring work-up for characterization. Target lesions may include those:

Incidentally detected, In subjects with chronic hepatitis or liver cirrhosis, In subjects with known history of malignancy.

• Is scheduled for surgical removal or biopsy of the target lesion from 24 hours to 30 days after the SonoVue® administration OR
• In case tissue biopsy is not indicated nor surgery planned, is scheduled for or has performed a CE-CT and/or CE-MRI of the target lesion from 30 days to 48 hours prior to or from 24 hours to 30 days after the administration of SonoVue®.

Exclusion criteria

• Has an acoustic window insufficient for adequate ultrasound examination of the liver.
• Has a FLL that cannot be identified with unenhanced ultrasound.
• Has received or is scheduled for antineoplastic chemotherapy or an invasive procedure in the time period between test procedures and truth standard assessments which may have modified the target lesion.
• Is receiving any other contrast medium, within the 48 hours before and up to 24 hours following the administration of SonoVue®.
• Has previously been enrolled in and completed this study.
• Known right to left cardiac shunt, bidirectional or transient.
• Has any known allergy to 1 or more of the ingredients of the investigational product (sulfur hexafluoride or to any components of SonoVue®).
• Has any contraindication to 1 of the planned imaging procedures (ultrasound, CT or MRI), e.g., implants, claustrophobia, inadequate medical conditions etc.
• Has received an investigational compound within 30 days before admission into this study.
• Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
• Is determined by the Investigator that the subject is clinically unsuitable for the study.
• Is a pregnant or lactating female. Exclude the possibility of pregnancy by:

testing on site at the institution serum βHCG within 24 hours prior to the start of SonoVue® administration, surgical history (e.g., tubal ligation or hysterectomy), post menopausal with a minimum 1 year without menses.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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353 participants in 1 patient group

Patients who received SonoVue

Other group

Description:

Patients with at least one target lesions requiring work-up for characterization to undergo * Unenhanced ultrasound of the target lesion (UE-US): gray scale and Doppler (color or power imaging) ultrasound investigations of the target lesion using commercially available ultrasound equipment and standard techniques (B-mode or Harmonic imaging) to study the anatomy of the target lesion and surrounding parenchyma; * SonoVue-enhanced ultrasound of the target lesion (CE-US):procedures described in protocol Section 7.5.1.2, to study the lesion vascularity in comparison to the surrounding parenchyma; and * Truth standard 2.4 mL of sulfur hexafluoride microbubbles (SonoVue®) will be administered as a bolus injection in a peripheral vein.

Treatment:

Drug: SonoVue®